NCT04946435

Brief Summary

This is an interventional study that will examine the effect of prophylactic topical antibiotics on nasal packing colonization following endoscopic skull base surgery.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

June 16, 2021

Last Update Submit

March 6, 2023

Conditions

Intracranial Pathology

Outcome Measures

Primary Outcomes (3)

  • Can prophylactic topical antibiotics alter the colonization of nasal packing following endoscopic skull base surgery

    The effect of prophylactic topical antibiotics on nasal packing colonization post-endoscopic skull base surgery will be measured using culture analysis. Colonization will be described as type(s) of bacteria.

    1 year

  • Can prophylactic topical antibiotics alter the bacterial load of nasal packing following endoscopic skull base surgery

    The effect of prophylactic topical antibiotics on the bacterial load of nasal packings post-endoscopic skull base surgery will be measured using culture analysis. Bacterial load will be measured in colony forming units (CFUs).

    1 year

  • Which bacteria colonize nasal packing following endoscopic skull base surgery

    The bacteria making up the colonization of nasal packing post-endoscopic skull base surgery will be identified using culture analysis.

    1 year

Secondary Outcomes (1)

  • Does endoscopic skull base surgery later the nasal flora

    1 year

Other Outcomes (1)

  • Does nasal packing colonization correlate with causative organisms

    1 year

Study Arms (2)

Drug: Antibiotic Irrigation, and Procedure/Surgery: Nasal Packing

EXPERIMENTAL

Experimental group will receive nasal packing with antibiotic irrigation.

Combination Product: Antibiotic Irrigation

Procedure/Surgery: Nasal Packing

ACTIVE COMPARATOR

Patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group.

Combination Product: Antibiotic Irrigation

Interventions

Antibiotic IrrigationCOMBINATION_PRODUCT

The first 30 patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group. The following 30 patients will be assigned to the experimental group. Immediately following surgery, the control group will receive nasal packing alone and the experimental group will receive nasal packing with antibiotic irrigation

Drug: Antibiotic Irrigation, and Procedure/Surgery: Nasal PackingProcedure/Surgery: Nasal Packing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary or revision endoscopic skull base surgery
  • Sellar or Intracranial pathology

You may not qualify if:

  • Patients with sinonasal malignancy
  • Prior radiation therapy
  • Concurrent sinusitis and/or nasal polyposis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

  • Carl Snyderman

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Participants will consist of 60 patients undergoing primary or revision endoscopic skull base surgery. The first 30 patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group. The following 30 patients will be assigned to the experimental group. Immediately following surgery, the control group will receive nasal packing alone and the experimental group will receive nasal packing with antibiotic irrigation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 30, 2021

Study Start

March 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 30, 2023

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)